The World Health Organization (WHO) has confirmed compliance with international quality standards for the Inactivated Split Influenza Vaccine produced by the Saint Petersburg’s Scientific Research Institute of Vaccine and Serum (SPbSRIVS), which is the parent company of the Latin-American Institute of Biotechnology MECHNIKOV in Nicaragua and supplies the bulk product of the vaccine for formulation, filling and packaging in our Plant. “After receiving prequalification from the WHO, SPbSRIVS will be able to export its vaccine as part of the dispatch for international supply foundations”, – the representative of the SPbSRIVS told TASS on Friday.
In February, the official representative of the WHO, Dr. Ute Rosskopf, responsible for interaction with laboratories, regulatory activities and safety, confirmed the full compliance of the influenza vaccine produced by the SPbSRIVS with world quality standards. “The WHO test result supports the acceptability of the Inactivated Split Influenza Vaccine produced by SPbSRIVS, Russian Federation, for prequalification” – the statement said.
Prequalification is a service provided by WHO to assess the quality, safety and efficacy of medicines. Together with SPbSRIVS, the MECHNIKOV Institute plans to receive prequalification of its vaccine in 2021. Prequalification by the WHO is a crucial condition for the access to the markets worldwide.